Environmental Monitoring – ISO 14644

Cleanrooms and controlled environments are utilized in order to control the levels of non-viable and viable particulates that medical devices and pharmaceutical products are exposed to during the manufacturing process. The objective of an environmental monitoring program is to estimate the microbial and particulate content of room air and surfaces. An effective environmental monitoring program can alert you when conditions contributing to excessive microbial levels arise due to ineffective cleaning, sanitation or other personnel/equipment issues. LCGC LABS can provide you with the appropriate level of service that you need to ensure your manufacturing environment complies with FDA, USP and ISO requirements.

Incubation and reporting of results (media, supplies and training are available if necessary)

Full validation including IQ, OQ, and PQ protocols and final reports to establish a sampling plan at appropriate sites, as well as determine appropriate alert or action levels for your manufacturing environment

A calibrated centrifugal air sampler is used to sample a defined volume of air, embedding viable particulates onto sterile media strips. The media strips are incubated to promote the growth of viable particulates, the microorganisms are enumerated and results are reported as the number of CFU (colony forming units) per volume of air sampled.

Surface Monitoring

Contact plates filled with media are used to sample tabletops, walls, benches, floors, garments, and gowned personnel to measure the number of microorganisms per area sampled. The media contains a neutralizer which inactivates cleaning and disinfection solutions to ensure that any microorganisms present are not inhibited from growing. The plates are incubated to promote growth, the microorganisms are enumerated and results are reported as the number of CFU (colony forming units) per area sampled.

Passive Air Monitoring

Settle plates filled with media are used to sample the microbial fallout over time. This type of sampling is qualitative and should not be used for quantitative estimations, but are good for sampling over longer periods of time and when used in conjunction with quantitative sampling methods. The plates are incubated to promote growth, the microorganisms are enumerated and results are reported as the number of CFU (colony forming units) per time sampled.

Non-Viable Particulate Monitoring

A calibrated laser particle counter is used to sample a defined volume of air. The particle counter can measure a variety of particle sizes, most commonly 0.5 and 5.0 micron particles. Particle counts are recorded as the number of particles per volume of air sampled. Results can be reported per cubic foot, per FDSTD 209E, or per cubic meter, per ISO 14644. Note that FDSTD 209E has been retired and ISO 14644 is the current guidance that should be followed when developing a new Cleanroom environment. Regardless many companies still use FEDSTD 209E.

Cleanroom/Controlled Environment Validation

Installation, Operation and Performance qualification protocols should be developed for controlled environments that establish the following:

Proper operation of the controlled environment and supporting equipment